Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire— 510(k) K152231

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K152231 for Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire, Substantially Equivalent on 2016-02-12. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2015-08-07
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.